04.25.2013 Fourth Circuit Upholds Lengthy “Stent” for Interventional Cardiologist
BY: JOHN STAIGE DAVIS, V
Can a cardiologist be sent to prison for performing medically unnecessary stent procedures, even though he stented a considerably lower percentage of his patients than his peers?
In United States v. McLean, No. 11-5130 (Apr. 23, 2013), the Fourth Circuit answered this question with a resounding “Yes.” Dr. McLean was a Maryland interventional cardiologist in private practice who performed cardiac catheterizations and coronary stent procedures at a regional medical center. In 2006, the medical center began investigating Dr. McLean’s stenting practices after a quality control review showed that he had placed a stent in a coronary artery with no significant blockage, or “stenosis.” An initial review showed that Dr. McLean had performed inappropriate stent procedures in 13 cases, and an outside contractor later confirmed that the doctor had performed unnecessary stents in approximately half of 25 randomly selected cases. Dr. McLean thereupon resigned his hospital privileges.
But his ordeal was only beginning. In 2007, the U.S. Attorney’s Office subpoenaed 117 patient files from Dr. McLean’s practice. After receiving information that the files “were in peril,” the government obtained a search warrant for his office. When FBI agents arrived to execute the warrant, they found subpoenaed files stacked on Dr. McLean’s desk, and a shred bin nearby. Dr. McLean admitted that he was removing documents from the files for shredding (although he later argued that the shredded documents, which included records from other doctors, fax cover sheets, prescription refills, and test results, were not material to the case.)
After a lengthy investigation, in 2010 the government indicted Dr. McLean for health care fraud and making false statements in connection with health care services between 2003 and 2006. The government’s theory was that Dr. McLean defrauded Medicare, Medicaid, and private insurers by submitting claims for medically unnecessary procedures and testing. The false statement charges pertained to records in which Dr. McLean deliberately overstated the level of stenosis in his patients’ arteries. As evidence of the doctor’s financial motive, the government showed that he purchased a $1.7 million condominium in 2004, around the same time that his Medicare claims for stent reimbursements increased dramatically.
After a 10-day trial in 2011 featuring “dueling experts,” the jury convicted Dr. McLean on all counts. He was later sentenced to imprisonment for 8 years, 1 month, and was subjected to forfeiture and restitution orders totaling more than $500,000. His sentence was based in part on a loss amount under the federal Sentencing Guidelines of more than $1 million, determined by adding the reimbursements he received ($579,070) from Medicare and private insurers for unnecessary stent procedures and related follow-up tests, plus the medical center’s repayment to federal programs of $1.3 million in a separate civil fraud settlement in 2011.
On appeal, Dr. McLean challenged the sufficiency of the evidence used to convict him. Among other things, he argued that the government’s “peer comparison evidence” showed that he stented only 16 out of 100 patients in his practice, a rate 67% lower than the average of his peers. But the Fourth Circuit was unimpressed, noting that the same evidence showed that Dr. McLean significantly exceeded the per-patient stent-placement rate of his peers: although his peers placed 1.15 stents in each patient, his average per patient was 2.03.
Dr. McLean also emphasized a 2009-10 study finding that some 12% of stents performed nationwide were medically unnecessary, and that his own error rate was “not much higher” – approximately 15-30% of all stent procedures he performed. In response, the court of appeals acknowledged that “pattern evidence” alone, showing that a physician placed more unnecessary stents than the national average, would not necessarily be probative of fraud. More important was evidence that Dr. McLean “repeatedly overstated blockage by a wide margin” in patient records, along with other evidence, including that he made misrepresentations to patients, and recorded symptoms patients did not experience, to create the illusion of medical necessity. The court also noted testimony that the “skill” Dr. McLean demonstrated in an appropriate stent procedure “demonstrated reasonable technique and the ability to discern appropriate treatment,” and thus undermined the possibility that the doctor was simply negligent.
McLean well illustrates the risks faced by the modern health care provider caught in the cross-hairs of an intensive criminal investigation by federal authorities. Even if a demonstrably competent physician provides medically necessary services to his patients in a clear majority of cases, and even if the physician employs a challenged elective service less frequently than his peers, he still can receive a lengthy prison sentence for performing and billing for medically unnecessary procedures.
McLean prompts at least three observations. The first is that fraudulent patient records may ensure a doctor’s conviction for health care fraud, even if other considerations militate in his favor. The most telling evidence against Dr. McLean was not the government’s “peer comparison” data regarding stent procedures, but the proof that he falsely and repeatedly overstated the level of stenosis of specific patients, contradicting the angiograms contained in his own files. The second observation is that in light of the federal dollars at stake, the “loss amount” driving a doctor’s prison sentence under the federal sentencing guidelines can quickly mushroom. Here, Dr. McLean was held directly accountable not just for the Medicare and private insurance reimbursements that his practice received for unnecessary stent procedures and related follow-up tests, but also for the far greater sum - $1.3 million – separately paid to the federal government by the medical center for reimbursements to “hospital facilities.” The third observation is the most obvious: the shredding of subpoenaed documents (even immaterial documents) rarely ends well for a criminal defendant!